efficacy and safety study of fluticasone furoate (ff)/gw642444 inhalation powder and the individual components in subjects with chronic obstructive pulmonary disease (copd)

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the purpose of this study is to assess the efficacy and safety of two strengths of the ff/gw642444 inhalation powder in subject with chronic obstructive pulmonary disease (copd)


Eligibility criteria:
inclusion criteria: * type of subject: outpatient * informed consent: subjects must give their signed and dated written informed consent to participate. * gender: male or female subjects a female is eligible to enter and participate in the study if she is of: * non-child bearing potential or * child bearing potential, has a negative pregnancy test at screening, and agrees to one of the acceptable contraceptive methods defined in the protocol * age: ≥40 years of age at screening (visit 1) * copd diagnosis: subjects with a clinical history of copd in accordance with the definition by the american thoracic society/european respiratory society \[celli, 2004\] * tobacco use: subjects with a current or prior history of ≥10 pack-years of cigarette smoking at screening (visit 1). * severity of disease: subjects with a screening (visit 1) measured post-albuterol/salbutamol: * fev1/fvc ratio of ≤0.70 and * fev1 ≤70% of predicted normal values * dyspnea: achieved a score of ≥2 on the modified medical research council dyspnea scale (mmrc) at screening (visit 1). exclusion criteria: subjects meeting any of the following criteria must not be enrolled in the study: * pregnancy: women who are pregnant or lactating or are planning on becoming pregnant during the study. * asthma: subjects with a current diagnosis of asthma * α1-antitrypsin deficiency: subjects with α1-antitrypsin deficiency as the underlying cause of copd * other respiratory disorders: subjects with active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases, or other active pulmonary diseases * lung resection: subjects with lung volume reduction surgery within the 12 months prior to screening (visit 1) * chest x-ray (or ct scan): subjects with a chest x-ray (or ct scan) that reveals evidence of clinically significant abnormalities not believed to be due to the presence of copd. * hospitalization: subjects who are hospitalized due to poorly controlled copd within 12 weeks of visit 1. * poorly controlled copd: subjects with poorly controlled copd, defined as the occurrence of the following in the 6 weeks prior to visit 1: acute worsening of copd that is managed by subject with corticosteroids or antibiotics or that requires treatment prescribed by a physician. * lower respiratory tract infection: subjects with lower respiratory tract infection that required the use of antibiotics within 6 weeks prior to visit 1. * other diseases/abnormalities: subjects with historical or current evidence of clinically significant cardiovascular (i.e., pacemaker), neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or haematological abnormalities that are uncontrolled. * peptic ulcer disease: subjects with clinically significant peptic ulcer disease that is uncontrolled. * hypertension: subjects with clinically significant hypertension that is uncontrolled. * cancer: subjects with carcinoma that has not been in complete remission for at least 5 years. carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded if the subject has been considered cured within 5 years since diagnosis. * drug/food allergy: subjects with a history of hypersensitivity to any of the study medication or components of the inhalation powder * drug/alcohol abuse: subjects with a known or suspected history of alcohol or drug abuse within the last 2 years * medication prior to spirometry: subjects who are medically unable to withhold their albuterol/salbutamol and/or their ipratropium 4 hours prior to spirometry testing at each study visit * additional medication: use of certain medications such as bronchodilators and corticosteroids for the protocol-specified times prior to visit 1 (the investigator will discuss the specific medications) * oxygen therapy: subjects receiving treatment with long-term oxygen therapy (ltot) or nocturnal oxygen therapy required for greater than 12 hours a day. oxygen prn use (i.e., ≤12 hours per day) is not exclusionary. * sleep apnea: subjects with clinically significant sleep apnea who require use of continuous positive airway pressure (cpap) device or non-invasive positive pressure ventilation (nippv) device. * pulmonary rehabilitation: subjects who have participated in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to screening (visit 1) or who will enter the acute phase of a pulmonary rehabilitation program during the study. * non-compliance: subjects at risk of non-compliance, or unable to comply with the study procedures. any infirmity, disability, or geographic location that would limit compliance for scheduled visits. * questionable validity of consent: subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study. * prior use of study medication/other investigational drugs * affiliation with investigator site: study investigators, sub-investigators, study coordinators, employees of a participating investigator or immediate family members of the aforementioned are excluded from participating in this study.

Keywords: copd chronic obstructive pulmonary disease efficacy fev1 safety